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Bill
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H.R. 501 — what changed

Block, Report, and Suspend Suspicious Shipments Act

From Introduced in House to Reported in House. 2 sections amended between Introduced in House and Reported in House.

Section 1 Short title

changed This Act may be cited as the “Block, Report, And and Suspend Suspicious Shipments Act ”.Act”.

Sec. 2 Block, report, and suspend suspicious orders

(a)
changed Clarification of process for registrants To exercise due diligence upon discovering a suspicious order— Paragraph (3) of section Section 312(a) of the Controlled Substances Act (21 U.S.C. 832(a)) is amended to read as follows:amended—
(1)
added in paragraph (2), by striking “and” at the end; and
(2)
added by striking paragraph (3) and inserting the following paragraphs:

added “(3) determine whether an order or series of orders is suspicious, taking into consideration—

added “(A) any unusual size, pattern, or frequency of the order or series of orders; and

added “(B) any customer business model, dispensing patterns, prior orders, or other characteristics that may indicate the order or series of orders is suspicious, despite the particular order or series of orders not exhibiting an unusual size, pattern, or frequency; and

added “(4) upon discovering suspicious circumstances regarding an order or series of orders, and in a manner consistent with the other requirements of this section—

added “(A) decline to fill the order or series of orders, establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the order or series of orders, and notify the Administrator of the Drug Enforcement Administration for the purpose of including information on such order or series of orders in the centralized database established under subsection (b)(1); or

added “(B) exercise due diligence as appropriate and—

added “(i)

added “(I) if the due diligence fails to dispel all of the indicators that give rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted, decline to fill the order or series of orders; or

added “(II) if the due diligence does dispel all such indicators, fill the order or series of orders;

added “(ii) establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the order or series of orders and the due diligence that was performed; and

added “(iii) notify the Administrator of the Drug Enforcement Administration for the purpose of including information on such order or series of orders in the centralized database established under subsection (b)(1), including any indicators giving rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted.”

removed “(3) upon discovering a suspicious order or series of orders, and in a manner consistent with the other requirements of this section—

removed “(A) exercise due diligence as appropriate;

removed “(B) establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the due diligence that was performed;

removed “(C) decline to fill the order or series of orders if the due diligence fails to dispel all of the indicators that give rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted; and

removed “(D) notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business of—

removed “(i) each suspicious order or series of orders discovered by the registrant; and

removed “(ii) the indicators giving rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted.”

(b)
changed Resolution of suspicious indicators—Regulations— Section 312 Not later than 1 year after the date of enactment of this Act, for purposes of section 312(a)(4) of the Controlled Substances Act (21 U.S.C. 832) is amended—Act, as inserted by subsection (a), the Attorney General of the United States shall promulgate a final regulation specifying—
(1)
changed by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; andthe indicators that give rise to a suspicion that, if an order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted;
(2)
changed by inserting after subsection (a) the following:a definition of due diligence; and
(3)
added in the case of a registrant that dispels all of the indicators giving rise to a suspicious order or series of orders, the circumstances in which the registrant is not required to file the notification under such section 312(a)(4).

removed “(b) Resolution of suspicious indicators—If a registrant resolves all of the indicators giving rise to suspicion about an order or series of orders under subsection (a)(3)—

removed “(1) notwithstanding subsection (a)(3)(C), the registrant may choose to fill the order or series of orders; and

removed “(2) notwithstanding subsection (a)(3)(D), the registrant may choose not to make the notification otherwise required by such subsection.”

(c)
changed Regulations—Penalty— Not later than 1 year after the date of enactment of this Act, for purposes of subsections (a)(3) and (b) of section 312 Section 402(a)(5) of the Controlled Substances Act, as Act (21 U.S.C. 842(a)(5)) is amended or inserted by subsection (a), the Attorney General of the United States shall promulgate a final regulation specifying the indicators that give rise to a suspicion that, if an order or series of orders is filled, inserting before the drugs that are semicolon at the subject of end the order or series following: “, including any such violation of orders are likely to be diverted.section 312(a)(4)”.
(d)
changed Penalty—Applicability— Section 402(a)(5) 312(a)(4) of the Controlled Substances Act (21 U.S.C. 842(a)(5)) is amended Act, as inserted by inserting before subsection (a), shall apply beginning on the semicolon at day that is 1 year after the end date of enactment of this Act. Until such day, section 312(a)(3) of the following: “or otherwise violates Controlled Substances Act shall apply as such section 312(a)(3)”.312(a)(3) was in effect on the day before the date of enactment of this Act.
(e)
changed Applicability—Sense of Congress— Subsections (a)(3) and (b) of section 312 of the Controlled Substances Act, as amended or inserted by subsection (a), shall apply beginning on the day that It is 1 year after the date of enactment of this Act. Until such day, section 312(a)(3) of the Controlled Substances Act shall apply as such section 312(a)(3) was in effect on the day before the date of enactment sense of this Act.Congress that—
(1)
added medications for opioid use disorder significantly reduce the risk of overdose death; and
(2)
added the requirements of this Act are not intended to impair access to controlled substances primarily used to treat opioid use disorder.